Acute Myeloid Leukemia Clinical Trial
Official title:
A Phase 1 Dose-Escalation Study of LAM-003 in Patients With Acute Myeloid Leukemia
A Phase 1 Dose-Escalation Study of LAM-003 in Patients with Acute Myeloid Leukemia
This clinical trial is a Phase 1 study evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of LAM-003 across a range of LAM-003 dose levels when administered to subjects with previously treated relapsed or refractory cute Myeloid Leukemia (AML). Subjects will self-administer oral LAM-003 either once or twice per day as long as they are safely benefitting from therapy. Cohorts of 3 to 6 subjects will be sequentially enrolled at progressively higher dose levels of LAM-003 using a standard 3+3 dose-escalation design. Based on the pattern of dose-limiting toxicities observed in the first 4 weeks of therapy, escalation will proceed to define a recommended LAM-003 dosing regimen. ;
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